Sr. Principal Scientist, Nonclinical Drug Safety

About the role

The Nonclinical Drug Safety Therapeutic Area Leader for Immunology drives the vision and scientific strategy for nonclinical development programs, regulatory submissions and post‑marketing support.

Key responsibilities

• Lead Immunology nonclinical programs, providing strategic oversight and risk assessments across discovery to late development.
• Develop and author regulatory documents (INDs, NDAs, BLAs, etc.) and engage with health authorities and scientific consortia.
• Coach and mentor Compound Leaders and Discovery Program Leaders, fostering a culture of empowerment and talent growth.
• Identify resource needs, prioritize projects, and proactively manage emerging risks within the therapeutic area.

Required profile

• PhD, DVM or MD with graduate/post‑graduate training in Toxicology, Immunology, Pharmacology, Pathology or related field.
• Minimum 12 years of experience in nonclinical drug development, toxicology and immunology, with strong regulatory knowledge (ICH, GLP).
• Proven leadership in matrixed environments, excellent communication skills and a track record of scientific publications or external collaborations.

Required skills

• Cell Line Engineering
• Clinical Judgment
• Drug Development
• Human Health Risk Assessment
• Innovative Thinking
• Mentorship
• Omics Technologies
• Pharmacodynamics
• Pharmacokinetics
• Product Registrations
• Project Leadership
• Risk Assessments
• Strategic Planning
• Toxicity Studies
• Toxicology